臨床研究等提出・公開システム

Date of registration	July. 28, 2026
Last modified on	July. 28, 2026
Trial ID	jRCT1050260121

Scientific Title	Safety, efficacy, and treatment outcomes of no-touch endoscopic full-thickness resection for gastric submucosal tumors: a retrospective observational study
Public Title	A retrospective study of treatment outcomes in patients who underwent no-touch EFTR for gastric submucosal tumors

Contact for Scientific Queries	Name	Uedo Noriya
	Affiliation	Osaka International Cancer Institute
	Address	3-1-69 Otemae Chuo-ku Osaka-shi Osaka-fu
	Telephone	+81-6-6945-1181
	E-mail	noriya.uedo@gmail.com
Contact for Public Queries	Name	Morita Muneshin
	Affiliation	Osaka International Cancer Institute
	Address	3-1-69 Otemae Chuo-ku Osaka-shi Osaka-fu
	Telephone	+81-6-6945-1181
	E-mail	muneshin.m7@gmail.com

Recruitment status	Recruiting

Anticipated date of first enrollment		July. 28, 2026
Target sample size		38
Study Type		Observational
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients who underwent no-touch endoscopic full-thickness resection for gastric submucosal tumors at Osaka International Cancer Institute between July 2023 and May 2026.
	Exclusion Criteria	Patients with insufficient medical records to evaluate the primary outcome, patients judged by the investigators to be inappropriate for inclusion in this study, or patients or their representatives who declined the use of their clinical information for this study.
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Gastric submucosal tumors, including gastrointestinal stromal tumors
Intervention(s)		Not applicable. This is a retrospective observational study using existing clinical information, and no intervention will be performed as part of this study.
Health Condition(s) Keyword		gastric submucosal tumor; gastrointestinal stromal tumor; endoscopic full-thickness resection; no-touch EFTR
Health Condition(s) Code		D018204
Primary Outcome(s)		Histological complete resection rate (R0 resection rate), defined as the proportion of patients with histologically negative margins of the entire tumor after no-touch EFTR.
Secondary Outcome(s)		Secondary outcomes include the endoscopic complete resection rate (ER0 resection rate), en bloc resection rate, time for lesion resection, time for defect closure, successful defect closure rate, postoperative adverse events, need for surgical intervention, days to resume oral intake, days to discharge, and the presence of tumor capsule injury or macroscopic tumor rupture.

Primary Sponsor	none

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Certified Review Board of Osaka International Cancer Center, Osaka Prefectural Hospital Organization (CRB5180012)
Address	3-1-69 Otemae Chuo-ku Osaka-shi Osaka-fu, Osaka
Telephone	+81-6-6945-1181
E-Mail	rinri01@opho.jp
Approval Status	Approval
Date of approval	July. 24, 2026

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none